A Phase 3 interventional study of Lamazym and Placebo in Alpha-Mannosidosis, sponsored by Zymenex A/S. Completed at 6 sites in 5 countries. Open to participants aged 5 Years to 35 Years. Per ClinicalTrials.gov, last updated 2020-08-03.
Sponsored by Zymenex A/S · Phase 3, Interventional, and Treatment
The overall objective of this trial is to evaluate the efficacy and safety of repeated Lamazym i.v. treatment, compared with placebo, in subjects 5-35 years of age with alpha-Mannosidosis
21 studies on the registry are indexed under Mannosidase Deficiency Diseases; 3 are open to participants now.
This study's enrollment of 25 is above the median of 12 across 12 interventional studies indexed under Mannosidase Deficiency Diseases.
Browse Mannosidase Deficiency Diseases studies →Zymenex A/S is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 mg Lamazym/kg body weight
Drug: Lamazym
Placebo is formulated as an isotonic phosphate buffer with glycine and mannitol
Drug: Placebo
ERT, i.v. infusions weekly
Also known as: rhLAMAN, recombinant human alpha-mannosidase
Infusions weekly
Reduction of oligosaccharides in serum
Primary efficacy endpoint evaluated as change from baseline in the active group versus the placebo group
Time frame: Baseline evaluation prior to first dose, midterm evaluation after 26 weeks, and end evaluation after 52 weeks
The number of steps climbed in 3 minutes (3-minute stair climb test)
Primary efficacy endpoint evaluated as change from baseline in the active group versus the placebo group
Time frame: Baseline evaluation prior to first dose, midterm evaluation after 26 weeks, and end evaluation after 52 weeks
Forced Vital Capacity
Secondary efficacy endpoint evaluated as change from baseline in the active group versus the placebo group
Time frame: Baseline evaluation prior to first dose, midterm evaluation after 26 weeks, and end evaluation after 52 weeks
The distance walked in 6 minutes (6-minute walk test)
Secondary efficacy endpoint evaluated as change from baseline in the active group versus the placebo group
Time frame: Baseline evaluation prior to first dose, midterm evaluation after 26 weeks, and end evaluation after 52 weeks
Adverse Events
Safety endpoint assessed weekly throughout the trial
Time frame: 1 week
Development of clinically significant changes in vital signs and change in physical examination
Safety endpoints assessed weekly throughout the trial
Time frame: 1 week
Clinical laboratory parameters (hematology, biochemistry and urinalysis)
Safety endpoints assessed weekly throughout the trial
Time frame: 1 week
Development of Lamazym antibodies and neutralizing/inhibitory antibodies
Safety endpoints assessed weekly throughout the trial
Time frame: 1 week
Quantitative determination of rhLAMAN in plasma
Pharmacokinetic (PK) assessments. Blood samples are drawn pre-treatment and at various times post-treatment (see time frame above)
Time frame: 10 min, 60 min, 2 hours, 24 hours, 3 days, 7 days
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Mannosidase Deficiency Diseases→
Zymenex A/S